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NINDS CREATE Bio Optimization Track for Biologics (U01)

PAR
Monday, August 14, 2017
Tuesday, September 8, 2020
U01
PAR-17-456
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene and cell therapies) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies. Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track. The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA).

NINDS CREATE Bio Optimization Track for Biologics (U44)

PAR
Monday, August 14, 2017
Tuesday, September 8, 2020
U44
PAR-17-457
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports SBIRs in the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging modalities) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic agent(s) that showed promise as evidenced by relevant, rigorous, convincing in vivo studies. Therefore, at the end of this funding period, successful projects will have delivered an optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track.

Administrative Supplement for the NINDS Research Education Program for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (Admin Supp)

PA
Friday, July 28, 2017
Friday, November 1, 2019
333
PA-17-442

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages administrative supplements for the NINDS Research Education Program for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (R25, PAR-13-384 and subsequent reissuances)

Administrative Supplements for the U.S.-Japan Brain Research Cooperative Program (BRCP) - U.S. Entity (Admin Supplement)

PA
Tuesday, July 18, 2017
Thursday, September 19, 2019
333
PA-17-326

Funding Opportunity Purpose

The National Institutes of Health (NIH) announces the continuation of the U.S. entity of the U.S.-Japan Brain Research Cooperative Program (BRCP). This administrative supplement program will provide funds to research projects that are currently supported by the participating NIH Institutes and Centers.

Clinical Research Sites for the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites) (U24)

RFA
Friday, June 30, 2017
Wednesday, September 27, 2017
U24
RFA-NS-17-024

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite currently awarded NeuroNEXT sites and potential new sites to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). This clinical research network develops and conducts multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies for neurological disorders, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials.

NINDS Neuroscience Development for Advancing the Careers of a Diverse Research Workforce (R25)

PAR
Monday, June 12, 2017
Thursday, September 26, 2019
R25
PAR-17-312

Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NINDS Neuroscience Development for Advancing the Careers of a Diverse Research Workforce R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce by (1) increasing the pool of current and future Ph.D.-level research scientists from diverse backgrounds underrepresented in biomedical neuroscience research; and (2) facilitating the career advancement/transition of the participants to the next step of their neuroscience careers.

NeuroNEXT Small Business Innovation in Clinical Trials (U44)

PAR
Monday, June 5, 2017
Saturday, January 6, 2018
U44
PAR-17-300

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm ).

PHS 2017-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42])

PA
Monday, June 5, 2017
Saturday, January 6, 2018
R41/R42
PA-17-303
Stephanie Fertig

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in response to identified topics (see PHS 2017-2 SBIR/STTR Program Descriptions and Research Topics for NIH.

PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

PA
Monday, June 5, 2017
Saturday, January 6, 2018
R43/R44
PA-17-302
Stephanie Fertig

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2017-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.

NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)

PAR
Wednesday, May 10, 2017
Monday, January 8, 2018
U01
PAR-17-274

Funding Opportunity Purpose

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

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